Intermittent Hypoxia Therapy in Cardiac Rehabilitation

NCT ID: NCT04034082

Last Updated: 2021-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2020-10-30

Brief Summary

This is a randomized control pilot study to assess the effect of intermittent hypoxia therapy on functional capacity vs conventional care in old patients with functional impairment admitted to a Phase 2 in-hospital cardiac rehabilitation program.

Detailed Description

Because the improvement of exercise tolerance reduces mortality in elderly patients affected by cardiovascular disease, intermittent hypoxia therapy (IHT) - defined as repeated episodes of hypoxia interspersed with normoxic periods delivered by an ad hoc device - might be a valuable tool to be associated to structured cardiac rehabilitation (CR) interventions.

The present study is a pilot, monocentric, randomized (randomization ratio 1:1), parallel group study to assess the effect of IHT on functional capacity vs conventional care in old patients with functional impairment admitted to a phase 2 in-hospital cardiac rehabilitation program.

The study will enroll cardiac patients of both genders, ≥ 75 years and with a functional impairment assessed by a Short Physical Performance Battery (SPPB) score < 7.

The effect of IHT on functional capacity will be evaluated on top of the conventional multidisciplinary CR intervention, by means of SPPB score variation; variations in quality of life and cognitive status will also be evaluated as secondary goals of the study.

The total amount of IHT sessions per patient will be 10, 1 per day over 2 weeks, the duration of each single procedure will be 45 min and the Hypoxic O2 conc.% will be 14-10. The study was approved by local ethic committee.

Conditions

Cardiovascular Disease; Exercise; Hypoxia

Keywords

cardiovascular disease; rehabilitation; exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IHT group

Intermittent hypoxia therapy on top of the conventional phase 2 in-hospital rehabilitation program

Group Type: EXPERIMENTAL

Intermittent hypoxia therapy

Intervention Type: DEVICE

Intermittent Hypoxic Therapy (further referred to as IHT). A typical IHT session consists of repeated short-term moderate hypoxia (down to 10 vol.% O2), interrupted by brief periods of reoxygenation. These periods of recovery could be either normoxic (21 vol.% O2, Hypoxia-Normoxia mode) or hyperoxic (30-35 vol.% O2, Hypoxia-Hyperoxia mode, further referred to as IHHT). The gas mixtures are supplied to a patient via facial mask.

Conventional phase 2 cardiac rehabilitation programme

Intervention Type: OTHER

The core components of a Phase 2 in-hospital cardiac rehabilitation program include: 1) patient assessment with medical control to promote clinical stabilization and optimization of pharmacologic treatment; 2) physical activity counselling; 3) prescription of an individualized exercise training; 4) diet/nutritional counselling; 5) weight control management; 6) Lipid management; 7) blood pressure monitoring and management; 8) smoking cessation; 9) vocational support; 10) psychosocial management..

Conventional group

Conventional phase 2 in-hospital rehabilitation program

Group Type: ACTIVE_COMPARATOR

Conventional phase 2 cardiac rehabilitation programme

Intervention Type: OTHER

The core components of a Phase 2 in-hospital cardiac rehabilitation program include: 1) patient assessment with medical control to promote clinical stabilization and optimization of pharmacologic treatment; 2) physical activity counselling; 3) prescription of an individualized exercise training; 4) diet/nutritional counselling; 5) weight control management; 6) Lipid management; 7) blood pressure monitoring and management; 8) smoking cessation; 9) vocational support; 10) psychosocial management..

Interventions

Intermittent hypoxia therapy

Intermittent Hypoxic Therapy (further referred to as IHT). A typical IHT session consists of repeated short-term moderate hypoxia (down to 10 vol.% O2), interrupted by brief periods of reoxygenation. These periods of recovery could be either normoxic (21 vol.% O2, Hypoxia-Normoxia mode) or hyperoxic (30-35 vol.% O2, Hypoxia-Hyperoxia mode, further referred to as IHHT). The gas mixtures are supplied to a patient via facial mask.

Intervention Type: DEVICE

Conventional phase 2 cardiac rehabilitation programme

The core components of a Phase 2 in-hospital cardiac rehabilitation program include: 1) patient assessment with medical control to promote clinical stabilization and optimization of pharmacologic treatment; 2) physical activity counselling; 3) prescription of an individualized exercise training; 4) diet/nutritional counselling; 5) weight control management; 6) Lipid management; 7) blood pressure monitoring and management; 8) smoking cessation; 9) vocational support; 10) psychosocial management..

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Admission to a Phase 2 in-hospital cardiac rehabilitation program because of a recent index event;
• Provision of signed and dated informed consent form;
• Age ≥ 75 years;
• Basic venous blood oxygen saturation (SpO2) level > 93% measured at the fingertip;
• SPPB score < 7;
• New York Heart Association (NYHA) Class I-III.

Exclusion Criteria

• Inability to give informed consent (diminished understanding or comprehension);
• Age < 75 years;
• SPPB Score ≥ 7;
• NYHA Class IV and/or concomitant i.v. therapy with cardiovascular active drugs;
• Uncontrolled angina pectoris;
• Uncontrolled arterial hypertension;
• Uncontrolled atrial or ventricular arrhythmias;
• Active pericarditis or myocarditis;
• Need of continuous or intermittent O2 therapy;
• Hb < 10 g/dl;
• Severe concomitant non-cardiac diseases such as cancer or any other systemic disease limiting to participate in the study
• Acute inflammatory diseases;
• Acute non-cardiac somatic diseases, or somatic diseases with symptoms of decompensation;
• Currently implanted left ventricular assist device;
• Inability to accept the procedure of breathing via facial mask.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Pedretti, MD

Role: STUDY_CHAIR

ICS Maugeri care and Research Institute, Pavia, Italy

Locations

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, , Italy

Countries

Italy

Other Identifiers

2233CE

Identifier Type: -

Identifier Source: org_study_id